BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELFOAM STERILE SPONGE

    MDR report key: 71678 · Received February 21, 1997

    Report

    Report Number
    1810189-1997-00008
    Event Type
    Malfunction
    Date Received
    February 21, 1997
    Report Date
    January 20, 1997
    Manufacturer
    PHARMACIA & UPJOHN CO.
    Product Code
    LMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LOT 61AHF WAS ACCEPTABLE AT THE TIME OF RELEASE AND WITHIN REGISTRATION SPECIFICATIONS. NO FURTHER INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELFOAM STERILE SPONGE Implant ABSORBABLE GELATIN SPONGE LMF PHARMACIA & UPJOHN CO. SIZE 12X7 61AHF

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention